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Cerliponase alfa

Alternative Names: cerliponase alfa, brineur, BMN-190, BMN190, BMN 190
Latest Update: 2024-07-24
Latest Update Note: News Article

Product Description

Cerliponase alfa (Brineura™) is a recombinant human tripeptidyl peptidase-1 (TPP1) being developed by BioMarin Pharmaceutical Inc. for use in patients with neuronal ceroid lipofuscinosis type 2 (CLN2), a paediatric neurodegenerative disease caused by a deficiency in TPP1.  (Sourced from: https://pubmed.ncbi.nlm.nih.gov/28589525/)

Mechanisms of Action: TPP1 Modulator

Novel Mechanism: No

Modality: Coagulation Factor

Route of Administration: N/A

FDA Designation: None *

Approval Status: Approved

Approved Countries: Australia | Austria | Belgium | Brazil | Canada | Croatia | Czech | Denmark | Estonia | European Medicines Agency | Finland | Germany | Greece | Hungary | Iceland | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lithuania | Netherlands | Poland | Portugal | Romania | Slovakia | Slovenia | Sweden | Taiwan | Ukraine | United Kingdom | United States

Approved Indications: CLN2 | Neuronal Ceroid-Lipofuscinosis

Known Adverse Events: Bradycardia | Hypotension | Seizures | Headache

Company: Biomarin
Company Location: NOVATO CA 94949
Company CEO: Jean-Jacques Bienaimé
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Cerliponase alfa

Countries in Clinic: Germany, Italy, United Kingdom, United States

Active Clinical Trial Count: 1

Highest Development Phases

Phase 2: CLN2|Neuronal Ceroid-Lipofuscinosis

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

NCT02678689

P2

Completed

CLN2|Neuronal Ceroid-Lipofuscinosis

2022-04-20

32%

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